Crossover Trial of AD036 in Obstructive Sleep Apnea

Completed · Phase 2 · Has a placebo group

Conditions studied: Obstructive Sleep Apnea

In brief

This is a randomized, 3-Period, Placebo-Controlled, Crossover, phase 2 clinical study to examine the efficacy and safety of AD036 versus placebo or atomoxetine in patients with obstructive sleep apnea.

Key facts

Study ID

NCT04445688

Run by

Apnimed

People needed

62

Starts

2020-07-15

Expected to finish

2020-12-01

Last updated by the study team

2023-09-14

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit.
• AHI 10 to <20, or AHI ≥20 if meets PSG criteria

You may not qualify if…

• History of narcolepsy.
• Clinically significant craniofacial malformation.
• Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
• CPAP should not be used for at least 2 weeks prior to first study PSG
• History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.

Where it is running

• Preferred Research Partners, Inc. — Little Rock, Arkansas, United States
• SDS Clinical Trials, Inc. — Santa Ana, California, United States
• The Center for Sleep and Wake Disorders — Chevy Chase, Maryland, United States
• Sleep Medicine & Research Center, St. Luke's Hospital — Chesterfield, Missouri, United States
• CTI Clinical Research Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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